Characterization of H4-IC31 candidate: particles and composition

DATE: August 31, 2017
TIME: 7:00am PT, 10:00am ET, 4:00pm CET

A tuberculosis (TB) vaccine consisting of a recombinant fusion protein (referred to as H4) combined with a novel synthetic cationic adjuvant, IC31®, is in development. The H4 fusion protein consists of two immunogenic mycobacterial antigens, Ag85B and TB10.4. The IC31® adjuvant is a mixture of KLK, a leucine-rich peptide (KLKL5KLK), and the oligodeoxynucleotide ODN1a, a TLR9 ligand.  This webinar will discuss Phase Analysis Light Scattering (PALS) and Raman spectroscopy methods to characterize the H4-IC31 vaccine formulation. The PALS method can be used to assess vaccine product quality and consistency in terms of particle size, zeta potential and conductivity. These parameters can differentiate between the IC31® adjuvant and the H4-IC31 vaccine candidate; hence, the method can serve as a control during vaccine formulation. Additionally, Electrical Sensing Zone (ESZ) was used as an orthogonal method to measure size of IC31 and H4-IC31 particles. Furthermore structural changes of H4 protein upon adjuvantation were characterized by Raman, FTIR and CD spectroscopy. The applicability of these biophysical methods to characterize vaccine components in the final H4-IC31 drug product without desorption will be discussed.